Phase 2 Completed N=268 Randomized Treatment

Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief

Postoperative Pain · Anxiety

Source: ClinicalTrials.gov NCT01394250 ↗

Enrolled (actual)

268

Serious AEs

0.0%

Results posted

May 2015

Primary outcomePrimary: Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation — -3.544; -3.436 units on a scale

Summary

The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical lidocaine cream in reducing the pain associated with IV cannulation.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation	-3.544; -3.436	—
SECONDARY Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups	0.667; 0.333	—

Eligibility Criteria

Inclusion Criteria

Subject is aged 4 to 18 years of age
Subjects will be having a peripheral IV line placed at the discretion of the treating physician for usual care of presenting complaints.
Physician in charge of the subject is willing to wait the 30 minutes needed for the study preparation
Subject/caregiver understands English
Parent or legal guardian has signed Institutional Review Board (IRB) approved informed consent and subject (if age 7 years or older) has given assent

Exclusion Criteria

Subject is critically ill with a triage category of 1
Subject has a condition that precludes the use of the self-report pain scale
Subject has an abrasion, infection or break in skin in the area where Buzzy® would be placed
Nerve damage is present in the extremity for planned IV placement

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01394250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.